Safety and Efficacy of Insulin Detemir Plus Insulin Aspart Against Insulin Glargine Plus Insulin Aspart as Mealtime Insulin in Type 1 Diabetes

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 1; Diabetes

• Registration Number: NCT00095082
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe and the United States of America (USA). The purpose of this study is to test whether insulin detemir is a safe and at least as effective alternative to insulin glargine for the control of blood glucose in basal/bolus therapy in patients with type I diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2004-10-29
• Study First Submitted QC: 2004-10-29
• Study First Posted: 2004-11-01
• Primary Completion: 2005-12
• Study Completion: 2005-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-26
• Last Update Posted: 2017-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 447

Inclusion Criteria

• Type 1 diabetes for at least 12 months
• Current treatment with basal-bolus insulin regimen for more than or equal to 3 months
• HbA1c less than or equal to 11.0%

Exclusion Criteria

• Proliferative retinopathy or maculopathy
• Recurrent major hypoglycaemia
• Impaired hepatic or renal function
• Cardiac problems or uncontrolled hypertension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HbA1c	after 1 year trial period

Secondary Outcome Measures

Name	Time	Method
Blood glucose
Adverse events
Body weight
Hypoglycemia
Insulin Treatment Satisfaction

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Wirral, Merseyside, United Kingdom